ASTAGRAF XL Drug Patent Profile
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When do Astagraf Xl patents expire, and when can generic versions of Astagraf Xl launch?
Astagraf Xl is a drug marketed by Astellas and is included in one NDA.
The generic ingredient in ASTAGRAF XL is tacrolimus. There are twenty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Astagraf Xl
A generic version of ASTAGRAF XL was approved as tacrolimus by SANDOZ on August 10th, 2009.
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Summary for ASTAGRAF XL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 80 |
| Clinical Trials: | 9 |
| Drug Prices: | Drug price information for ASTAGRAF XL |
| What excipients (inactive ingredients) are in ASTAGRAF XL? | ASTAGRAF XL excipients list |
| DailyMed Link: | ASTAGRAF XL at DailyMed |
Recent Clinical Trials for ASTAGRAF XL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Colorado, Denver | Early Phase 1 |
| Cedars-Sinai Medical Center | Phase 4 |
| Medical University of South Carolina | Phase 4 |
Pharmacology for ASTAGRAF XL
| Drug Class | Calcineurin Inhibitor Immunosuppressant |
| Mechanism of Action | Calcineurin Inhibitors |
Paragraph IV (Patent) Challenges for ASTAGRAF XL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ASTAGRAF XL | Extended-release Capsules | tacrolimus | 0.5 mg, 1 mg, and 5 mg | 204096 | 1 | 2013-09-24 |
US Patents and Regulatory Information for ASTAGRAF XL
ASTAGRAF XL is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting ASTAGRAF XL
FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-001 | Jul 19, 2013 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-002 | Jul 19, 2013 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-003 | Jul 19, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ASTAGRAF XL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-003 | Jul 19, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-001 | Jul 19, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-001 | Jul 19, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ASTAGRAF XL
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Astellas Pharma Europe B.V. | Modigraf | tacrolimus | EMEA/H/C/000954 Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients. |
Authorised | no | no | no | 2009-05-15 | |
| Astellas Pharma Europe BV | Advagraf | tacrolimus | EMEA/H/C/000712 Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients. |
Authorised | no | no | no | 2007-04-23 | |
| Chiesi Farmaceutici S.p.A. | Envarsus | tacrolimus | EMEA/H/C/002655 Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients. |
Authorised | no | no | no | 2014-07-18 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ASTAGRAF XL
See the table below for patents covering ASTAGRAF XL around the world.
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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